Fresh Vs Frozen Surgical Sperm in IVF

January 13, 2022 updated by: Reproductive Medicine Associates of New Jersey

Randomized Controlled Trial Comparing Fresh Vs Frozen Surgical Sperm in In Vitro Fertilization Cycles

The primary objective of this study is to determine if the use of frozen surgical testicular sperm specimens for ICSI lead to different IVF outcomes when compared with the use of fresh surgical testicular sperm for ICSI.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The study seeks to isolate the effect of slow freezing and thawing of surgical sperm specimens on fertilization and embryo blastulation rates by utilizing a randomized controlled split cohort protocol including men with obstructive azoospermia undergoing surgical sperm retrieval and good-prognosis female patients.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Reproductive Medicine Associates of New Jersey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Females age < 42 with an indication for IVF
  • Females with lowest AMH level 1.2 ng/mL or higher
  • Females with FSH < 13 mIU/mL
  • Sperm obtained via Surgical retrieval (any type) for IVF only
  • Use of comprehensive chromosome screening (CCS) to screen embryos for aneuploidy
  • BMI < 35
  • Baseline antral follicle count of > 8
  • Single embryo transfers only

Exclusion Criteria:

  • Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.
  • Contraindication to IVF
  • Clinical indication for preimplantation genetic diagnosis (PGD) (i.e., screening for single gene disorder, chromosomal translocation, or any other disorders requiring detailed embryo genetic analysis)
  • Fewer than 4 mature oocytes retrieved (will not randomize)
  • Male partner with non-obstructive azoospermia
  • Male partner with any Karyotype other than 46,XY
  • Male partner with history of spinal cord injury
  • Male partner with Kallman's syndrome
  • History of chronic oligomenorrhea
  • History of hydrosalpinges or adnexal mass
  • History of endometrial insufficiency (max endometrial thickness < 7mm)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Fresh surgical testicular sperm
Fresh, surgically obtained testicular sperm
Experimental: Frozen surgical testicular sperm
Surgically obtained testicular sperm that will undergo slow freezing and thawing
Other: Slow Freezing and Thawing
half of the surgically obtained testicular sperm will be frozen for 30 minutes and subsequently thawed prior to performing ICSI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blastulation Rate
Time Frame: 5-7 days post ICSI procedure
total number of embryos reaching the blastulation stage of development
5-7 days post ICSI procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertilization Rate
Time Frame: 1 day post ICSI
number of 2PNs
1 day post ICSI
Time to Find Sperm in Fresh Specimen
Time Frame: up to 6 hours post surgery
total amount of time spent finding sperm in the fresh surgical testicular sperm sample
up to 6 hours post surgery
Post-thaw recovery rate of frozen surgical sperm
Time Frame: 30 minutes after freezing
analysis of sperm parameters post freezing
30 minutes after freezing
Aneuploidy Rate
Time Frame: 2 weeks post trophectoderm biopsy
number of chromosomally normal and abnormal embryos
2 weeks post trophectoderm biopsy
Implantation Rate
Time Frame: approximately 4-6 weeks post embryo transfer
presence of fetal heart beat at discharge to obstetric care
approximately 4-6 weeks post embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Reproductive Medicine Associates of New Jersey

Investigators

  • Principal Investigator: Ashley Tiegs, MD, Reproductive Medicine Associates of New Jersey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2019

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

November 29, 2017

First Submitted That Met QC Criteria

November 29, 2017

First Posted (Actual)

December 5, 2017

Study Record Updates

Last Update Posted (Actual)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 13, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMA-2017-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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